ATUSA 3D automated breast ultrasound for suspicious breast lesions

ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE), a Case Collection Registry for 3D Breast Automated Ultrasound Using ATUSA System as Well as Other Breast Imaging Modalities.

This study will test whether the ATUSA 3D automated breast ultrasound system can produce high-quality images that match biopsy results in women with BI-RADS 4 or 5 breast findings.

Quick facts

• Study type: Observational
• Enrollment: 800 (estimated)
• Ages: 18 Years to 94 Years
• Sex: Female
• Sponsor: iSono Health, Inc. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Sacramento, California)
• Trial ID: NCT07505797 on ClinicalTrials.gov

What this trial studies

AUDIBLE is a multi-site observational registry in the United States collecting 3D automated breast ultrasound images using the iSono Health ATUSA system from up to 800 female patients with BI-RADS 4 or 5 findings referred for biopsy. Participants will undergo ATUSA imaging in addition to their standard-of-care imaging and the study will gather multi-modality images, medical record data, and biopsy histopathology. The protocol examines image quality, reproducibility, and how ATUSA findings correlate with radiologist-assigned BI-RADS categories and histopathology, and follows a subset of patients receiving neoadjuvant therapy longitudinally. Collected data will be centralized to support device validation and a comprehensive imaging registry.

Who should consider this trial

Good fit: Women aged 18 to 94 with a recent BI-RADS 4 or 5 breast imaging result who are scheduled for biopsy and can attend imaging and follow-up visits are ideal candidates.

Not a fit: Patients who are pregnant or breastfeeding, have incompatible breast anatomy or recent breast surgery/treatment, active skin lesions, MRI-incompatible implants, or a prior bilateral mastectomy are unlikely to benefit or may be ineligible.

Why it matters

Potential benefit: If successful, ATUSA could provide more consistent, reproducible ultrasound images that better correspond to biopsy results and help clinicians make more accurate diagnostic decisions, especially in patients with dense breasts.

How similar studies have performed: Automated 3D breast ultrasound systems (ABUS) have shown promising results, particularly for lesion detection in dense breasts, but device-specific validation data for ATUSA remain limited.

Eligibility criteria

Inclusion Criteria:

1. Provide written informed consent through a signed and dated consent form.
2. Demonstrate commitment to complete all study requirements and maintain availability for the full study duration.
3. Be female, aged 18 to 94 years (inclusive).
4. Have a recent BI-RADS® 4 or 5 classification confirmed through breast imaging and medical records.

Exclusion Criteria:

1. Active skin lesions (open wounds or unhealed sores) on either breast.
2. Implanted medical devices (pacemakers, defibrillators) or MRI incompatible materials that cannot be temporarily removed.
3. Current pregnancy or breastfeeding status (self-reported).Documented hypersensitivity to silicone or gadolinium-based contrast agents.
4. Previous bilateral mastectomy.
5. Physical inability to maintain a supine position for 30 minutes.
6. Breast anatomy incompatible with ATUSA device specifications.
7. Recent (within 12 months) breast surgery or cancer treatment.
8. Negative findings on diagnostic ultrasound examination within 30 days of Screening, but prior to initiating study required procedures.
9. Any medical or psychological condition that, in the Principal Investigator's judgment, could affect study participation or data integrity.

Where this trial is running

Sacramento, California

• UC Davis — Sacramento, California, United States (Recruiting)

Study contacts

• Study coordinator: Neda Rezavi

Conditions Breast Cancer; Benign Breast Condition; Breast Fibroadenoma; Breast Neoplasms; Breast Disease; Breast Cancer Female; Breast Pain; Breast Cancer Invasive